US-backed vaccine trial on babies canceled after international outcry

Key Points:

• Guinea-Bissau's government formally rejected a clinical trial led by Danish researchers, funded by the US, which aimed to study alleged nonspecific harms from the newborn hepatitis B vaccine dose, a globally recommended and long-used vaccine.
• The trial was widely criticized by the WHO and experts as unethical because it would withhold the vaccine from half of the newborn participants, putting them at risk of chronic hepatitis B infection and its severe consequences.
• The US CDC awarded $1.6 million to Bandim Health Project for the trial, sparking outrage due to the researchers’ controversial reputation and ongoing investigations for alleged scientific misconduct.
• Guinea-Bissau authorities raided Bandim Health’s offices and seized vaccines intended for the trial after the rejection, amid local mistrust fueled by media coverage portraying the trial as dangerous and suspicions of vaccine testing on newborns.
• Bandim Health researchers stated the trial will not proceed in Guinea-Bissau and emphasized that any future study must have local support and meet ethical and governmental approvals.